1-12
Introduction to MR Conditional Pacing
X-ray or Fluoroscopic Identification
• A pulsed radio frequency (RF) field produced by transmission RF coils (approximately 64
MHz for 1.5 T and 128 MHz for 3 T).
These fields may create physical forces or electrical currents that can affect the functioning of
active implantable medical devices (AIMDs) such as pulse generators and leads. Therefore,
only patients implanted with an MR Conditional system are eligible to be scanned. Furthermore,
by complying with the MRI Conditions of Use, outlined in this Technical Guide ("MRI Conditions
of Use" on page 1-4), ImageReady MR Conditional System patients can undergo MRI scans with
risks mitigated to the best current standard of care.
X-RAY OR FLUOROSCOPIC IDENTIFICATION
The primary means of identification of the implanted device and lead(s) should be the patient's
medical files. To provide additional means of identification of the device, images of the pulse
generators as visible under X-ray or fluoroscopy are shown in Table 1–6 Pulse Generator Images
on page 1-12.
Table 1–6. Pulse Generator Images
Pulse Generator Images
Pulse Generators X-Ray Identifier Approximate Location on Device (1)
ESSENTIO MRI
PROPONENT MRI
ACCOLADE MRI
MR CONDITIONAL PACING SYSTEM WARNINGS AND PRECAUTIONS
General
WARNING: Unless all of the MRI Conditions of Use ("MRI Conditions of Use" on page 1-4) are
met, MRI scanning of the patient does not meet MR Conditional requirements for the implanted
system, and significant harm to or death of the patient and/or damage to the implanted system
may result.
For potential adverse events applicable when the Conditions of Use are met or not met, see
"Potential Adverse Events" on page 1-14.
NOTE: Table 1–4 Cardiology Conditions/Patient Conditions on page 1-6 and Table 1–5
Radiology Conditions on page 1-8 provide information on the nature of the increased risk(s)
associated with the failure to meet each Condition of Use. This information is intended to assist in
performing a risk/benefit analysis to decide whether or not to scan a patient who does not meet
all the stated criteria for MR Conditional status. Alternatives including other imaging methods
may also be considered.
WARNING: Only the combination of INGEVITY MRI lead(s) with an ESSENTIO MRI,
PROPONENT MRI, or ACCOLADE MRI pulse generator is valid to use with either 1.5 T or 3 T
scanners. All other allowable combinations of Boston Scientific MR Conditional system
components must use only 1.5 T scanners.
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